U.S. patent number 8,702,658 [Application Number 13/340,445] was granted by the patent office on 2014-04-22 for iv catheter insertion device and method.
The grantee listed for this patent is William L. Spearman. Invention is credited to William L. Spearman.
United States Patent |
8,702,658 |
Spearman |
April 22, 2014 |
IV catheter insertion device and method
Abstract
An IV catheter insertion device includes a flash chamber into
which blood (or other fluid) flows to confirm the proper placement
of the catheter. Within the device is a movable member which is
controlled from outside, as by a health care worker moving a
plunger to move the movable member and expel blood from the flash
chamber through the needle for testing or other analysis. The
plunger may have a locking and unlocking mechanism to present the
movement of the plunger from occurring when it is not desired.
Inventors: |
Spearman; William L. (Beaufort,
SC) |
Applicant: |
Name |
City |
State |
Country |
Type |
Spearman; William L. |
Beaufort |
SC |
US |
|
|
Family
ID: |
48695445 |
Appl.
No.: |
13/340,445 |
Filed: |
December 29, 2011 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20130172820 A1 |
Jul 4, 2013 |
|
Current U.S.
Class: |
604/168.01;
604/165.01 |
Current CPC
Class: |
A61M
25/0693 (20130101); A61M 25/0631 (20130101); A61M
5/178 (20130101); A61M 2005/3112 (20130101) |
Current International
Class: |
A61M
5/178 (20060101) |
Field of
Search: |
;604/168.01,165.01 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Bouchelle; Laura
Assistant Examiner: Landry, II; Gerald
Attorney, Agent or Firm: Seaman; Kenneth A.
Claims
Having thus described the invention, what is claimed is:
1. A catheter insertion device comprising a housing carrying a
needle, a flash chamber connected to the needle with a flash plug
filter, the flash chamber providing a visual indicator of fluid
when the needle of the catheter has been inserted into a fluid
supply, and further including a movable member mounted to the
housing and coupled to the flash chamber, said movable member
moving from a first position to a second position within the flash
chamber to expel fluid for testing from the flash chamber, said
movable member being moved after fluid is within the flash chamber
to expel fluid.
2. A catheter insertion device of the type described in claim 1
wherein the flash chamber includes a vent in front of or behind the
movable member, the vent allowing the movable member to move to
expel the fluid without creating a vacuum.
3. A catheter insertion device of the type described in claim 1
wherein the flash chamber includes a vent in front of or behind the
movable member, the vent allowing air to escape the flash chamber
as the chamber fills with blood or fluid while blocking the blood
or fluid from escaping the chamber.
4. A catheter insertion device of the type described in claim 1
wherein the movable member is located toward the proximal portion
of the flash chamber and is moved distally toward the needle to
force fluid from the chamber.
5. A catheter insertion device of the type described in claim 1
wherein a lever coupled to the movable member extends through the
housing and movement of the lever causes movement of the movable
member to expel fluid from the flash chamber.
6. A catheter insertion device of the type described in claim 1
wherein the movable member is coupled to the flash chamber thereby
not requiring the operator to open the flash chamber to access the
blood or fluid within the flash chamber.
7. A catheter insertion device of the type described in claim 1 and
further including a locking/unlocking mechanism to selectively
restrict movement of the movable member from the first
position.
8. A catheter insertion device of the type described in claim 7
where the locking mechanism includes a notch on the movable member
and a projection associated with the housing, with the projection
on the movable member fits within the notch in one position, but
the movable member may be moved to release the projection from the
latch to allow the movable member to become unlocked.
9. A catheter insertion device of the type described in claim 8
wherein the movable member has a rotary motion to release the
projection from the notch to allow the movable member to become
unlocked.
10. A catheter insertion device of the type described in claim 1
wherein the movable member includes a handle and a shaft, with the
shaft coupling to a flash plug to move the flash plug within the
flash chamber to expel fluid from the flash chamber through the
needle.
11. A catheter insertion device of the type described in claim 10
wherein the movable member includes structure which restricts its
movement and a release mechanism to allow the movable member to
move.
12. A catheter insertion device of the type described in claim 11
wherein the housing has a cylindrical shape and the movable member
includes a handle which is mounted for rotational movement with
respect to an axis of the housing and for translation along the
axis of the housing, with the rotational movement about the axis
allowing for the release of the structure which restricts its
movement and allows for translation along the axis of the housing
when it is released.
13. A catheter insertion device of the type described in claim 1
wherein the flash chamber includes a flash plug which is not
removable and the movable member moves the flash plug within the
flash chamber to expel blood from the flash chamber.
14. A catheter insertion device of the type described in claim 1
wherein the flash chamber includes a flash plug which is removable
and the movable member fits through the flash plug to move the
flash plug within the flash chamber from a first position to a
second position, where the movement to the second position serves
to expel fluid from the flash chamber.
15. A method of using a catheter insertion device including a
needle and a flash chamber connected to the needle to provide a
show of blood within the flash chamber as an indication that the
intravenous catheter has been inserted within a vein, the flash
chamber having a flash plug with a filter, the improvement
comprising the steps of: securing a moveable member to the catheter
insertion device and adjacent the flash chamber behind the show of
blood and the flash plug; moving the movable member forward toward
the needle to urge the blood out of the flash chamber to
controllably release blood from the flash chamber through the
needle; and testing the blood.
16. A method of using a catheter insertion device including the
steps of claim 15 and further including the step of unlocking the
movable member.
17. A method of using a catheter insertion device including the
steps of claim 16 wherein the step of unlocking the movable member
includes the step of rotating the movable member.
18. A method of using a catheter insertion device including the
steps of claim 17 wherein the step of rotating the movable member
includes the step of positioning a fixed projection on one of the
housing and the movable member within a slot to allow the movable
member to translate along the axis of the housing.
19. A method of using a catheter insertion device to provide a
sample of fluid from a patient, the catheter insertion device
having a housing with a needle, a flash chamber coupled to the
needle to receive fluid during the insertion of the catheter and a
flash plug to allow gas to escape from the flash chamber while
retaining the fluid within the flash chamber, the steps of the
method comprising: integrating a movable member within the housing
and positioning the movable member adjacent to the flash chamber
and cooperating with the flash plug; and after the catheter has
been inserted in the patient and the flash chamber contains fluid
from the patient, moving the movable member and flash plug to expel
fluid from the flash chamber through the needle.
20. A method of using a catheter insertion device including the
steps of claim 19 and further including the step of providing the
movable member with a locking mechanism to restrict its motion
while locked and an unlocking mechanism to allow the movable member
to move within the housing.
21. A method of using a catheter insertion device including the
steps of claim 20 wherein the method includes the step of unlocking
the movable member by rotating the member within the housing to
release it from its locking mechanism.
22. A catheter insertion device comprising a housing carrying a
needle, a flash chamber connected to the needle, the flash chamber
providing a visual indication of fluid when the needle of the
catheter has been inserted into a fluid supply, and further
including a movable member mounted to the housing and coupled to
the flash chamber, said movable member moving from a first position
to a second position within the flash chamber to expel fluid from
the flash chamber, said movable member being moved after fluid is
within the flash chamber to expel fluid, further including a lever
coupled to the movable member extending through the housing and
movement of the lever causes movement of the movable member causes
movement of the movable member to expel fluid from the flash
chamber.
23. A catheter insertion device of the type described in claim 22
wherein the flash chamber includes a vent in front of or behind the
movable member, the vent allowing the movable member to move to
expel the fluid without creating a vacuum.
24. A catheter insertion device of the type described in claim 22
wherein the movable member includes a handle and a shaft and the
movable member with the shaft coupling to a flash plug to move the
flash plug within the flash chamber to expel fluid from the flash
chamber, said movable member including structure which restricts
its movement and a release mechanism to allow the movable member to
move, wherein the housing has a cylindrical shape and the movable
member includes a handle for rotational movement with respect to an
axis of the housing and for translation along the axis of the
housing, with the rotational movement along the axis allowing for
the release of the structure which restricts its movement and
allows for translation along the axis of the housing when it is
released.
25. A catheter insertion device of the type described in claim 22
wherein the flash chamber includes a flash plug which is not
removable and the movable member moves the flash plug within the
flash chamber to expel blood from the flash chamber.
26. A method of using a catheter insertion device including a
needle and a flash chamber connected to the needle to provide a
show of blood within the flash chamber as an indication that the
intravenous catheter has been inserted within a vein, the flash
chamber having a flash plug and flash plug filter, the improvement
comprising the steps of: securing a movable member to the catheter
insertion device and adjacent the flash chamber, flash plug and
flash plug filter, behind the show of blood; unlocking the movable
member; and moving the movable member forward toward the needle to
urge the blood out of the flash chamber to controllably release
blood from the flash chamber through the needle.
27. A method of using a catheter insertion device including the
steps of claim 26 wherein the step of unlocking the movable member
includes the step of rotating the movable member.
28. A method of using a catheter insertion device including the
steps of claim 27 wherein the step of rotating the movable member
includes the step of positioning a fixed projection on one of the
housing and the movable member within a slot to allow the movable
member to translate along the axis of the housing.
29. A method of using a catheter insertion device to provide a
sample of fluid from a patient, the catheter insertion device
having a housing with a needle to receive fluid during insertion of
the catheter and a flash plug to allow gas to escape from the flash
chamber while retaining the fluid within the flash chamber, the
steps of the method comprising: integrating a movable member within
the housing and positioning the movable member adjacent to the
flash chamber and cooperating with the flash plug; providing the
movable member with a locking mechanism to allow the movable member
to move within the housing; and after the catheter has been
inserted in the patient and the flash chamber contains fluid from
the patient, moving the movable member an the flash plug to expel
fluid from the flash chamber through the needle.
30. A method of using a catheter insertion device including the
steps of claim 29 wherein the method includes the step of unlocking
the movable member by rotating the member within the housing to
release it from its locking mechanism.
Description
BACKGROUND OF THE INVENTION
A patient admitted to a hospital, an outpatient treatment center,
or an outpatient surgery center will have an intravenous (IV)
catheter inserted for easy access for fluids and drugs to be
administered to the patient. The IV catheter is typically inserted
using an IV insertion device, and some of these IV insertion
devices have become known in the industry as JELCOs after the name
of one company which brought these insertion devices to market. It
is frequently necessary for a sample of the patient's blood to be
obtained--e.g., for testing, blood typing or other analysis. For
many of these blood tests, only a small sample of blood is
required. After the IV catheter has been inserted, the healthcare
worker may obtain this blood sample by various means. One method
would be to have the patient endure another needle stick either by
a needle and syringe to draw an aliquot of blood or by pricking the
patient's finger with a lancet for a few drops of blood.
Some have proposed to use some of the blood that remains within the
JELCO or IV catheter insertion device after the IV catheter has
been inserted in a patient. Most IV catheter insertion devices
include an integrated flash chamber. Red blood appears within the
flash chamber of an IV catheter insertion device as the operator
inserts the needle of the IV catheter insertion device into the
vein to show that the IV catheter has entered a vein. The operator
watches the flash chamber continuing to fill with blood as the
operator advances the IV catheter into the vein, thereby ensuring
the IV catheter remains properly positioned within the vein.
Usually the proximal end of the flash chamber is blocked by a flash
plug. The flash plug typically includes a filter material that
allows air to vent from the flash chamber as the blood or fluid
fills the chamber, but prevents the blood or fluid from passing
from the flash chamber. IV catheter insertion devices of the prior
art may have one of two different types of flash plugs. An IV
catheter insertion device, such as described in U.S. Pat. No.
5,000,740, has a fixed or non-removable flash plug. Another type of
prior art IV catheter insertion device is seen in U.S. Pat. No.
4,917,671 with a removable flash plug.
When an IV catheter has been placed within the vein, the remainder
of the JELCO or IV catheter insertion device is removed from the
patient. A small amount of the patient's blood remains within the
flash chamber of the JELCO or IV catheter insertion device. By
accessing the patient's blood from the flash chamber of the IV
catheter insertion device, the operator may be able to avoid an
additional needle stick to the patient. There are some known
approaches to access blood in the flash chamber of an IV catheter
insertion device. One such approach in IV catheter insertion
devices with a non-removable flash plugs involves using an external
probe, such as a pen or a golf tee, to push an internal flash plug
within the flash chamber to expel blood from the flash chamber. The
use of an external device such as a golf tee or pen is undesirable
for several reasons. The external device must be stored some place
that is easily accessible to the operator. The use of an external
device is inefficient as the worker must look for or gather
additional equipment when accessing the captured blood or fluid and
replace the additional equipment for its next use. If the worker
were to reuse any external probe or device (including a pen or a
golf tee), cross-contamination may occur from one flash chamber to
another, putting other patients and the healthcare worker at
risk.
In IV catheter insertion devices that have removable flash plugs,
another prior art approach to access the blood in a flash chamber
requires the healthcare worker to remove the flash plug, thereby
opening the flash chamber to access the blood within the flash
chamber for testing. This action may unnecessarily expose the
healthcare worker to hazardous material (such as blood or other
bodily fluid) that may spill from the flash chamber.
While various prior art methods may allow the healthcare worker to
access the blood or fluid within the flash chamber of an IV
catheter insertion device (or JELCO), these methods present
inefficient and undesirable aspects and limitations to the health
care worker.
The present invention addresses some of these undesirable
limitations and aspects to provide an improved device and method
for accessing blood from an IV catheter insertion device without
the use of undesirable additional hardware and without unnecessary
risks. This new method and device will thereby increase the
efficiency of the healthcare worker and reduce the hazardous
exposure of bodily fluids to the workers and patients.
SUMMARY OF THE INVENTION
The present invention provides a system and method for providing a
self-contained system for removing blood (or other fluid) from an
IV catheter insertion device (or JELCO) in a controlled manner upon
demand and with greater ease and less risk to the worker.
The present invention has the advantage of reducing the number of
needle sticks to a patient by using blood or bodily fluid that has
been collected within the IV catheter insertion device when the IV
catheter is placed. That is, the fluid sample used for testing is a
by-product of the use of the IV catheter insertion device.
Applicant teaches in this patent application that blood collected
within the flash chamber of an intravenous catheter insertion
device can be accessed with an integral structure safely and
efficiently. The blood or fluid thus collected can be used for
analysis or testing without requiring the healthcare worker to
inflict additional needle sticks to a patient.
It is desirable that an IV catheter insertion device (or JELCO) be
simple to make and maintain in a sterile condition. It is also
desirable that the device be self-contained and not require
additional tools, e.g., an external device like a golf tee in order
to access the blood contained in the flash chamber.
It is also desirable that the operator be able to access the blood
or fluid within the IV catheter insertion device without having to
open the flash chamber, thereby reducing the chance for exposure of
hazardous material to the worker and patient.
The present invention overcomes the disadvantages and limitations
of the prior art systems while providing a simple, yet effective,
way of accessing the blood contained in the flash chamber of an IV
catheter insertion device for testing and analysis.
Other objects and advantages of the present invention will be
apparent to those of ordinary skill in the art in view of the
following detailed description of the preferred embodiment taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1a is a perspective view of one type of prior art IV catheter
insertion device (a JELCO);
FIG. 1b is a cross sectional view of the IV catheter insertion
device of FIG. 1a;
FIG. 2 is an exploded view of portions of the IV catheter insertion
device of FIGS. 1a and 1b, modified to include one form of the
present invention;
FIG. 3 is a cross sectional view of the IV catheter insertion
device of FIGS. 1a, 1b and 2, showing one form of the present
invention;
FIG. 4 is a perspective, exploded view of portions (one example of
a plunger and cap assembly) of the invention, prior to assembly of
them into the IV catheter insertion device;
FIG. 5 shows side and bottom views of the plunger of FIG. 4;
FIG. 6 is a perspective and cutaway view of the cap shown in FIG.
4;
FIG. 7 is a perspective, exploded view of an alternate type of
prior art IV catheter insertion device having a removable flash
plug;
FIG. 8 is a perspective view of an assembly of the removable flash
plug of FIG. 7, augmented with a plunger of the present invention
in its primary position;
FIG. 9 is a perspective view of the removable flash plug and
plunger of FIG. 8 with the plunger extended to its secondary
position;
FIG. 10 is a perspective view of the removable flash plug and
plunger of FIG. 9 being inserted into the alternate type of IV
catheter insertion device shown in FIG. 7;
FIG. 11 is a view of the components of FIG. 10 assembled
together;
FIG. 12 is a view of the IV catheter insertion device after
insertion of the IV catheter has been inserted and the remainder of
the device removed; and
FIG. 13 is a view of the IV catheter insertion device of FIG. 12
with the plunger moved forward to expel blood (or other fluid) from
the flash chamber of the insertion device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The following illustrates the use of the preferred embodiment of
this new method and device.
FIG. 1a illustrated one example of a prior art IV catheter
insertion device (which medical personnel sometimes referred to as
a "JELCO") 1. The IV catheter insertion device 1, shown enlarged
and in perspective in this view, includes an IV catheter 2, a
distal end 3 and a barrel 4 at a proximal end 4a. This FIG. 1a
illustrates one example of an IV catheter insertion device 1 having
a non-removable flash plug at the proximal end of a flash chamber
(not shown in this view), the construction and operation of an
example of which system is more fully described in detail in U.S.
Pat. No. 5,000,740, the specification and drawings of which are
specifically incorporated herein by reference.
FIG. 1b depicts more detail for the IV catheter insertion device 1
of one prior art JELCO which forms one environment for the present
invention. This FIG. 1b shows a cut-away view of the IV catheter
insertion device 1 shown in FIG. 1a and includes the barrel 4, a
flash plug 5, a flash chamber 6, and a needle 7 with a distal tip
7a and a proximate end 8 which communicates with the flash chamber
6. The barrel 4 of the IV catheter insertion device 1 and the flash
chamber 6 are both formed from a transparent material, such as a
plastic, so that one can clearly see through the barrel 4 into the
flash chamber 6, so that when blood enters into the flash chamber
6, the red color of the blood is clearly visible outside the IV
catheter insertion device 1. The needle 7 includes an internal
aperture extending from its distal tip 7a to its proximate end 8
adjacent the flash chamber 6, so that when distal tip 7a of the
needle 7 is properly inserted within a patient's vein (not shown),
blood from the vein can enter the flash chamber 6 (and be visible
to an observer looking from outside the IV catheter insertion
device 1).
FIG. 2 is an exploded view of selected components of the IV
catheter insertion device 1 of the present invention (but not all
of the components). The needle 7 includes its distal tip or end 7a
and a proximate end 8 which is secured within the flash chamber 6
of the IV catheter insertion device 1. The flash chamber 6 is
contained within the barrel handle 4b and is shown with screw
threads 6c at the proximate end 6a of the flash chamber 6. The
flash plug 5 comprises a flash plug filter 11, a rubberized seal 12
and a cap 13. The cap 13 includes internal threads (not shown)
which couple with the screw threads 6c on the flash chamber 6 when
the device 1 is fully assembled and ready for use. The proximate
end 8 of the needle is secured within the flash chamber 6 and
sealed so that the blood flows from the distal end 7a of the needle
7 to the flash chamber 6 where it is secured. A plunger 20 is
formed by a shaft 14 and a handle 15 and is mounted through a
central aperture in the cap 13. This plunger 20, through its shaft
14 and handle 15, can be moved by a user through apertures
extending through the cap 13 and the rubberized seal 12 to press
against the flash plug filter 11 and move the flash plug filter 11
away from the operator within the flash chamber 6 to expel blood,
as desired, from the distal end 7a of the needle 7.
In one preferred embodiment as seen in FIG. 3, the plunger 20
including the shaft 14 and the handle 15 extend through the cap 13
which can be seen coupled to the proximal portion of the flash
chamber 6. The healthcare worker, or operator, uses the IV catheter
insertion device 1 to insert an IV catheter in the usual manner. As
the operator inserts the needle tip 7a into the vein, the flash
chamber 6 fills with blood. In this embodiment, as the operator
advances the IV catheter, the barrel 4 (which serves as a needle
guard) advances distally over the distal tip 7a of the needle 7. As
the barrel or needle guard 4 advances distally over the needle 7,
the shaft 14 and handle 15 of the invention becomes exposed for the
operator. With the IV catheter insertion device 1 in this locked
position, the operator can position the distal tip 7a of the needle
7 over a testing strip or blood receiving cassette. The operator
then grasps the handle 15 and rotates the shaft 14 and handle 15
enough to disengage the shaft 14 from its locked position. Using
the handle 15, the operator advances the shaft 14 and plunger 20
from the proximal position in the flash chamber 6 to the distal
position of the flash chamber 6. The action of moving the shaft 14
and plunger 20 from its retracted position to its forward position
will force the blood or fluid within the flash chamber 6 back
through the needle 7 and to exit at the distal tip 7a of the needle
7. As the blood or fluid is expressed from the needle tip 7a, the
operator can direct this blood or fluid onto a testing strip or
other blood receiving container such as a cassette or cartridge.
The entire IV catheter insertion device 1 (other than the IV
catheter 2, which remains within the vein of the patient) can then
be disposed of properly into a hazardous waste container.
FIG. 4 shows detail of the plunger 20 including the shaft 14 and
the handle 15 as used in the environment of FIGS. 1a-3 as described
above. The shaft 14 includes a plurality of grooves extending along
the length of the shaft 14, two of which are shown in this FIG. 4
as reference numerals 17a and 17c. A notch 16 cooperates with one
groove 17a to form a locking mechanism in cooperation with a
projection 18 in the cap 13. The plunger 20 is initially locked
with the projection 18 fitting within the notch 16, then the
operator rotates the handle 15 of the plunger 20 in the direction
of the arrow R to release the locking mechanism and allow the
plunger 20 including shaft 14 and handle 15 to move in the
direction of arrow P along the length of the shaft by allowing the
projection 18 to move along the groove 17a.
FIG. 5 illustrates the elements of FIG. 4 in a bottom view and a
side view to better understand the present invention. As shown
here, the plunger 20 includes an enlarged handle 15 which is
generally round and fits within the barrel 4 of the IV catheter
insertion device 1. The shaft 14 is also generally cylindrical and
of a smaller diameter to fit within an aperture through the cap 13
which fits within the barrel 4 of the device 1. Grooves 17a, 17b,
17c are shown disposed around the periphery of the shaft 14. The
notch 16 is adjacent to and cooperating with one groove 17a to
provide a locking (and releasing) mechanism for the plunger 20
along the length of the shaft 14.
FIG. 6 are a perspective view and a cut-away view which illustrate
detail of the cap 13 and its projection 18 which cooperates with
the notch 16 to provide locking and unlocking the shaft 14 of the
plunger 20 and, when unlocked, allows the shaft 14 of the plunger
20 and the flash plug 11 to move forward within the flash chamber
6. The cap 13 includes internal screw threads 19 which mate with
the screw threads 6c of the flash chamber 6 when the device is
assembled.
In another embodiment, the present invention can be used in
conjunction with an alternate IV catheter insertion device 9 which
includes a removable flash plug 10 as is illustrated in FIG. 7.
FIG. 7 shows some of the components in a prior art IV catheter
insertion device 9 of the type described in connection with U.S.
Pat. No. 4,917,671, a patent whose drawings and specification are
incorporated herein by reference. The IV catheter insertion device
shown in this FIG. 7 includes the IV catheter 2, the needle 7
extending from the distal needle tip 7a at its distal end 3 to its
flash chamber 6 with a removable flash plug 10. The removable flash
plug 10 has a handle 10a and a leur tip 10b which connects within
the flash chamber 6. The present invention involves
substitution/modification of a modified plunger assembly 20a
including a handle 15a and a removable flash plug for the flash
plug 10 shown in this FIG. 7 as will be described in connection
with later illustrations, particularly FIGS. 8-10. This
substitution can occur, as desired, either during the initial
manufacture and assembly of the IV catheter insertion device 9 or
at the point of use e.g., bedside, using sterile techniques,
preferably immediately prior to the operator inserting the IV
catheter into the patient.
FIG. 8 shows the handle 15a and the shaft 14a of the modified
plunger assembly 20a in their initial position extending through
the removable flash plug 10 with its handle 10a and its leur tip
10b. A shaft end piece 14b is mounted on the other side of the leur
tip 10b from the handle 15a.
FIG. 9 shows the relative positions of the handle 15a, shaft 14a,
the shaft end piece 14b, and the flash plug 10 when the plunger 20a
has been extended (when it has been moved to expel blood from the
flash chamber 6, not shown in this view). A significant portion of
the shaft 14a extends below the leur tip 10b. The shaft end piece
14b consists of filter material to allow air to vent and prevents
fluid from escaping.
FIG. 10 shows the components of the IV insertion device 9 of the
present invention in an exploded view. As shown here, the IV
insertion device 9 includes a needle 7, an IV catheter 2, a flash
chamber 6 and the plunger assembly 20a of FIGS. 8-9 with the handle
15a and the shaft 14a.
FIGS. 11-13 show the IV catheter insertion device 9 as discussed in
connection with FIGS. 7-10 wherein FIG. 11 shows the device prior
to insertion of the IV catheter into a patient, FIG. 12 shows the
device 9 after the IV catheter has been inserted into a patient and
blood appears within the flash chamber 6 and the IV catheter 2
removed, and then FIG. 13 shows the device of FIG. 12 with the
handle 15a moved forward in the direction of arrow P to expel blood
from the flash chamber 6 to the distal end 7a of the needle 7 as
indicated by the arrow B. Initially in FIG. 11 the plunger 20a
including the handle 15a and the shaft 14a are at a rear or
withdrawn position and preferably locked against accidental
movement of the plunger 20a. After the IV is inserted into the
patient, the IV catheter 2 is detached from the remainder of the IV
insertion device 9 and the flash chamber 6 has become filled with
blood 6d and the flash plug 14b is at the rear or proximate end of
the flash chamber 6. The handle 15a and shaft 14a may be unlocked
by rotating them to release them from the locking mechanism and
moved forward or distally from the original position to a position
as shown in FIG. 13. As the shaft 14a and handle 15a are moved
forward, the shaft end (filter) 14b is also moved forward and urges
the blood from the flash chamber 6 distally through the needle 7
out its distal tip 7a, where drops of blood 6d are shown.
An example of this embodiment can be seen in FIGS. 8-10. These
figures illustrate from proximal to distal, a shaft handle 15a, a
shaft 14a, a handle 10a with a luer-tip connector 10b through which
the shaft 14a passes. The shaft 14a and handle 15a form a plunger
20a cooperating with the with filter material 14b to vent air as
blood enters the flash chamber but prevents blood or fluid from
escaping through the flash plug 10. The plunger may or may not have
a rubberized seal to seal the plunger within the walls of the flash
chamber 6. In this embodiment, the standard flash plug 10 has been
removed and replaced by the assembly of the present invention 20a
including the handle 10a with the plunger having its handle 15a and
shaft 14a which has been inserted into and secured within the flash
chamber 6 using the luer connector 10b. The operator is then ready
to insert the IV catheter 2. The operator will insert the IV
catheter 2 in the usual manner. After the IV catheter 2 has been
inserted and secured, the operator removes the remainder of the IV
insertion device 9. The operator then moves the deployed IV
catheter insertion device 9 with blood or fluid within the flash
chamber 6 to a position over a testing strip or cassette. The
operator will grasp the handle 15a and rotate the handle 15a and
the shaft 14a enough to unlock the locking mechanism. The operator
will then push the handle 15a to move the shaft 14a and filter 14b
at the distal end of the shaft 14a within the flash chamber 6 from
the proximal position 6a within the flash chamber 6 (FIG. 12) to
the distal position 6b within the flash chamber 6 (FIG. 13). The
movement of the shaft 14a and filter 14b in the direction of arrows
P from the position of FIG. 12 to the position of FIG. 13 will
force the blood or fluid through the needle 7 in the direction of
the arrow B toward the distal end 7a of the needle 7. As the blood
or fluid (represented by drops of blood 6d) is expressed from the
distal tip 7a of the needle 7, the operator can direct this blood
or fluid 6d onto a testing strip or cassette (not shown). The
operator can then dispose of the entire IV insertion device 9 (with
the IV catheter 2 removed and remaining installed within the
patient) into a hazardous materials container. Because the
invention has replaced the removable flash plug 10 prior to
insertion of the IV catheter 2, the operator can access the blood
or fluid 6d within the flash chamber 6 without opening the flash
chamber 6 or removing the flash plug 10, thereby reducing the
possibility of exposure of hazardous material to the operator or
patient.
Of course, many modifications to the best mode described above may
be effected without departing from the spirit of my invention.
Further, some of the features disclosed may be useful without the
corresponding use of other features. For example, the use of an
internal plunger within a rigid chamber could be replaced with a
flexible flash chamber with an external, but integral, compression
device for squeezing the flash chamber to expel blood out of the
flash chamber. Further, the specific construction of the plunger
and its coupling to the flash plug could be changed to advantage in
some alternate embodiments of the present invention, and any
locking and unlocking of the plunger is optional, as is any system
for limiting the advance of the plunger. Further, if desired, the
plunger could be provided with a system which limits the speed at
which the plunger moves forward to provide a controlled method for
expelling blood or other fluid from the flash chamber, even to the
extent of limiting the blood removal to a drop at a time. The
materials of the IV catheter insertion device including the barrel
and the flash chamber are typically made from a transparent plastic
material for easy of manufacture and durability as well as easy
visual inspection of the flash chamber, but other materials,
including glass, could be used for the barrel and the flash
chamber, and need not be wholly transparent (a window or a
translucent system might be used to advantage, if desired). Many
other modifications could be used to advantage in some cases
involving the present invention. Additionally, a different access
point to the blood in the flash chamber could be used, if desired,
in some instances. For example, an aperture with a cover in the
wall of the flash chamber and/or the barrel of the insertion device
might be opened to access the blood contained in the flash chamber
and allow for an operator to expel blood on demand using a plunger
or other pressure-applying force to remove blood through the
aperture and cover, a system which avoids exposing the sharp needle
of the catheter insertion device. Additionally, the insertion
device has been described in connection with a catheter insertion
device which accesses blood from a vein, but the present invention
would also be applicable to a device which accesses other body
fluids, such as spinal fluid, pleural fluid, ascites, other body
fluids, or even some body tissues. Accordingly, the foregoing
description of the preferred embodiment should be considered as
merely illustrative of the principles of the present invention and
not in limitation thereof. The scope of the present invention is to
be determined solely by the claims which follow.
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